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Completed

NCT Number: NCT01796301

An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women

The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

55 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal women, aged ≥ 55 to ≤ 90.
  • Received oral bisphosphonate therapy for at least 3 years immediately prior to screening
  • BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck
  • History of nonvertebral fracture after age 50, or vertebral fracture.

Exclusion criteria

  • Use of other agents affecting bone metabolism including Strontium ranelate, fluoride (for osteoporosis), odanacatib (MK-0822) or any other cathepsin K inhibitor, IV bisphosphonates, denosumab, teriparatide (TPTD) or any parathyroid hormone (PTH) analogs, Systemic oral or transdermal estrogen, selective estrogen receptor modulators (SERMs), activated vitamin D3, vitamin K2, calcitonin, tibolone, cinacalcet, systemic glucocorticosteroids:
  • History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of study results, such as sclerosteosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome.
  • Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 20 ng/mL, as determined by the central laboratory.
  • Current hyper- or hypocalcemia
  • Current, uncontrolled hyper- or hypothyroidism

Treatment and study plan

Romozosumab

Drug

Administered by subcutaneous injection once a month.

Other names: AMG 785

Teriparatide

Drug

Administered by subcutaneous injection once a day.

Other names: Forteo, Forsteo

Primary outcomes

  1. Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD)

    Time frame: Baseline, month 6 and month 12

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12.

Secondary outcomes

  1. Percent Change From Baseline in Total Hip BMD at Month 6

    Time frame: Baseline and month 6

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

  2. Percent Change From Baseline in Total Hip BMD at Month 12

    Time frame: Baseline and month 12

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

  3. Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6

    Time frame: Baseline and month 6

    Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.

  4. Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12

    Time frame: Baseline and month 12

    Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.

  5. Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6

    Time frame: Baseline and month 6

    Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.

  6. Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12

    Time frame: Baseline and month 12

    Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.

  7. Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6

    Time frame: Baseline and month 6

    Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.

  8. Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12

    Time frame: Baseline and month 12

    Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.

  9. Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6

    Time frame: Baseline and month 6

    Total hip integral BMC was measured using quantitative computed tomography (QCT).

  10. Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12

    Time frame: Baseline and month 12

    Total hip integral BMC was measured using quantitative computed tomography (QCT).

  11. Percent Change From Baseline in Femoral Neck BMD at Month 6

    Time frame: Baseline and month 6

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

  12. Percent Change From Baseline in Femoral Neck BMD at Month 12

    Time frame: Baseline and month 12

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

  13. Percent Change From Baseline in Lumbar Spine BMD at Month 6

    Time frame: Baseline and month 6

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

  14. Percent Change From Baseline in Lumbar Spine BMD at Month 12

    Time frame: Baseline and month 12

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

An Open-label, Randomized, Teriparatide-controlled Study to Evaluate the Effect of Treatment With Romosozumab in Postmenopausal Women With Osteoporosis Previously Treated With Bisphosphonate Therapy

Acronym: STRUCTURE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 21, 2013
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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